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[S13] Challenges on Implementation of Risk Based Approach and Its Foresight
Session Chair(s)
Shigeyoshi Yokokawa, MSc
Director, Regional Clinical Operations
Bristol-Myers Squibb K.K., Japan
Accompanied by implementation of ICH E6 R2, pharmaceutical companiesand CRO companies have taken the introduction of Risk Based Monitoring (RBM) into considerations, however, their stance is just like a “wait-and-see”. The primary objectives of RBM implementation are to ensure clinical trial data with high quality and to expect synergy brought by building processes at an investigational site and detecting issues promptly. On the other hand, it’s also true the discussion around its methodology is preceded. In this session, we would like to share the cases collaborated with an industry organization and investigational in accord with the results of survey. And we would also like to discuss our challenges on implementation of RBM which we have faced.
Speaker(s)
Let’s Go Back Again to the Basics of RBM
Yoko Kurose, MPharm
Pfizer R&D Japan, Japan
Senior Manager, Monitoring Group
What is Required of CRAs in Relation to RBM? ~Problems Revealed from a Survey of Medical Institutions
Toshiya Hara
I'ROM GROUP Co., Ltd., Japan
Executive Vice President
Road to RBM Realization- Learning from Site Tour
Minoru Koizumi
Eli Lilly Japan K.K., Japan
Senior Associate, Clinical Development Consultant